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Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients


Phase 1
35 Years
75 Years
Not Enrolling
Both
Neoplasm

Thank you

Trial Information

Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients


Inclusion Criteria:



- Healthy volunteers only

- Males/females, >/=50 and
- Cancer patients only

- Males/females >/= 35 years and
- Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy
response assessment that still showed tumor mass

Exclusion Criteria:

- Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g.
poorly controlled diabetes, congestive heart failure, myocardial infarction within 12
months prior to planned injection of BAY85-8050, unstable and uncontrolled
hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could
compromise participation in the study

- Known sensitivity to the study drug or components of the preparation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visual assessment of lesions

Outcome Time Frame:

Within up to 2 hours after treatment

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Food and Drug Administration

Study ID:

13107

NCT ID:

NCT00961831

Start Date:

April 2009

Completion Date:

December 2009

Related Keywords:

  • Neoplasm
  • Neoplasm
  • PET/CT diagnosis
  • PET tracer
  • Neoplasms

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